Dietary Collagen Peptides and Periodontal Inflammation

NCT03765125 | Completed

• 1 other identifier: VERIPA17
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized, double-blind, placebo-controlled 2-arm, parallel group clinical trial is designed to evaluate the impact of the regular consumption of collagen peptides on the clinical signs of gingival and periodontal inflammation in a cohort of patients suffering from periodontal disease.

Conditions

Gingivitis

Keywords

gingivitis; collagen peptide; plaque

Outcome Measures

Primary Outcomes (1)

• Percentage of periodontal sites being positive for bleeding on probing (BoP)

  Bleeding on probing will be recorded at 6 sites per tooth after gentle probing of the periodontal sulcus/pocket.

  90 days

Secondary Outcomes (8)

• clinical attachment level (CAL)

  90 days

• pocket probing depth (PPD)

  90 days

• periodontal inflamed surface area (PISA)

  90 days

• modified Gingival Index

  90 days

• Plaque Control Record

  90 days

Study Arms (2)

collagen peptide test

EXPERIMENTAL

1 x daily consumption of 1 blister package of the collagen-peptide test powder dissolved in water over a period of 90 days

Dietary Supplement: collagen peptide test

collagen peptide placebo

PLACEBO COMPARATOR

1y daily consumption of 1 blister package of the placebo powder dissolved in water over a period of 90 days

Dietary Supplement: collagen peptide placebo

Interventions

collagen peptide test DIETARY_SUPPLEMENT

Collagen peptides from bovine skin with an average molecular weight of approx. 2,000 g/mol. Average particle size is about 150 μm.

Also known as: collagen peptide placebo

collagen peptide test

collagen peptide placebo DIETARY_SUPPLEMENT

collagen peptide placebo

collagen peptide placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• number of teeth ≥ 10
• age ≥ 35 ≤ 70 years
• body mass index (BMI) ≥ 24 ≤ 30
• presence of mild to moderate gingivitis (Gingiva Index \> category GI 0 ≤ category GI 2) at a minimum of 3 teeth

You may not qualify if:

• manifestation of inflammatory oral mucosal diseases other than gingivitis
• xerostomia (salivary flow ≤ 0.1 ml/minute)
• inability for regular oral home care
• inability to follow the study protocol due to intellectual or physical handicaps
• history of malignancy, radiotherapy, or chemotherapy for malignancy in the past 5 years
• current pregnancy
• acute infections as HIV
• existence of metabolic bone disease
• smoking status of more than 10 cigarettes/day
• use of antibiotics and/or anti-inflammatory medication within 4 weeks prior to screening.
• active orthodontic therapy
• diabetes mellitus type I and II
• regular consumption of medications interfering with gingival inflammation (e.g. cortisol)

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (2)

Dept. of Periodontology, University Hospital Wuerzburg

Würzburg, 97070, Germany

Location

Section of Periodontology

Würzburg, D-97070, Germany

Location

MeSH Terms

Conditions

Gingivitis; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Yvonne Jockel-Schneider, Dr.

  Wuerzburg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: test and placebo powder contained in coded blister packages of identical shape and colour Handing out of the assigned powder by a study nurse not involved in the clinical examination and data collection
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized, double-blind, placebo-controlled 2-arm, parallel group

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 5, 2018
• Study Start: September 1, 2018
• Primary Completion: August 26, 2019
• Study Completion: August 31, 2019
• Last Updated: June 2, 2022

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)